Active ingredient
- sodium zirconium cyclosilicate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 17901/0332.
Lokelma 5 g & 10 g powder for oral suspension
Package Leaflet: Information for the patient
Lokelma 5 g powder for oral suspension
Lokelma 10 g powder for oral suspension
sodium zirconium cyclosilicate
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Lokelma is and what it is used for
2. What you need to know before you take Lokelma
3. How to take Lokelma
4. Possible side effects
5. How to store Lokelma
6. Contents of the pack and other information
1. What Lokelma is and what it is used for
Lokelma contains the active substance sodium zirconium cyclosilicate.
Lokelma is used to treat hyperkalaemia in adults. Hyperkalaemia means that there is a high level of potassium in the blood.
Lokelma lowers the high levels of potassium in your body and helps to keep it at a normal level. As Lokelma passes through your stomach and gut it attaches to potassium and the two are carried together out of the body in your stools, lowering the amount of potassium in the body.
2. What you need to know before you take Lokelma
Do not take Lokelma
Warnings and precautions
Monitoring
Your doctor or nurse will check your blood potassium level when you start taking this medicine:
While you are taking Lokelma, tell your doctor or nurse if
Talk to your pharmacist or doctor if you need Lokelma 5 g or more daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age. This is because the effects of Lokelma in children and adolescents are not known.
Other medicines and Lokelma
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
In particular, tell them about any medicines which can change your blood potassium levels because your dose of Lokelma may need to be changed. These include:
Also, tell your doctor or nurse if you are taking any of the following:
If any of the above apply to you (or you are not sure), tell your doctor, pharmacist or nurse before taking this medicine.
Pregnancy and breast feeding
Pregnancy
Do not use this medicine during pregnancy because there is no information on its use in pregnancy.
Breast-feeding
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Lokelma is negligible. Lokelma can be used during breast-feeding.
Driving and using machines
This medicine has no or negligible influence on your ability to drive or to use machines.
Lokelma contains sodium
This medicine contains approximately 400 mg sodium (main component of cooking/table salt) in each 5 g dose. This is equivalent to 20% of the recommended maximum daily dietary intake of sodium for an adult.
3. How to take Lokelma
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
Starting dose - to lower your high potassium level to normal:
Maintenance dose - to keep your potassium level within the normal range after it has been lowered:
If you are on haemodialysis therapy:
Taking this medicine
How to take
If you take more Lokelma than you should:
If you take more of this medicine than you should, talk to a doctor straight away. Do not take any more until you have spoken to a doctor.
If you forget to take Lokelma
If you stop taking Lokelma
Do not reduce the dose of this medicine or stop taking it without talking to the doctor who prescribed it. This is because you may get high potassium levels in your blood again.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or nurse if you experience any of the following:
Common side effects (may affect up to 1 in 10 people).
Not known (frequency cannot be estimated from the available data).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lokelma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the sachet after ‘EXP’. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Lokelma contains
The active substance is sodium zirconium cyclosilicate.
Lokelma 5 g powder for oral suspension
Each sachet contains 5 g of sodium zirconium cyclosilicate.
Lokelma 10 g powder for oral suspension
Each sachet contains 10 g of sodium zirconium cyclosilicate.
There are no other ingredients in this medicine.
What Lokelma looks like and contents of the pack
The powder for oral suspension is a white to grey powder. It comes in a sachet.
Lokelma 5 g powder for oral suspension
Each sachet contains 5 g of powder.
Lokelma 10 g powder for oral suspension
Each sachet contains 10 g of powder.
The sachets are supplied in a carton containing 3, 28 or 30 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 02/2021
© AstraZeneca 2021
Lokelma is a registered trademark of the AstraZeneca group of companies.
CV 21 0017
Other sources of information
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Reference number
Lokelma 5 g powder for oral suspension 17901/0332
Lokelma 10 g powder for oral suspension 17901/0331
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